TADALAFIL Zentiva 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

TadalafilZentiva5 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Tadalafil Zentiva and what is it used for
2. What you need to know before taking Tadalafil Zentiva
3. How to take Tadalafil Zentiva
4. Possible side effects
5. Storage of Tadalafil Zentiva
6. Contents of the pack and further information

1. What is Tadalafil Zentiva and what is it used for

Tadalafil Zentiva contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.

Tadalafil Zentiva 5 mg is used for the treatment of adult men with:

• erectile dysfunction. This is when a man cannot get or maintain an erection that is sufficient for satisfactory sexual activity. Tadalafil has been shown to significantly improve the ability to get an erection that is sufficient for sexual activity. After sexual stimulation, tadalafil works by helping to relax the blood vessels in the penis, allowing blood to flow into the penis. The result is an improvement in erectile function. Tadalafil will not help if you do not have erectile dysfunction. It is important to note that tadalafil is not effective if there is no sexual stimulation.

• urinary symptoms associated with benign prostatic hyperplasia. This is when the prostate gland gets bigger with age. Symptoms include difficulty starting to urinate, feeling like the bladder is not completely empty, needing to urinate more often, even at night. Tadalafil improves blood flow and relaxes the muscles of the prostate and bladder, which can reduce the symptoms of benign prostatic hyperplasia. Tadalafil has been shown to improve these urinary symptoms in as little as 1-2 weeks after starting treatment.

2. What you need to know before taking Tadalafil Zentiva

Do not take Tadalafil Zentiva:

• if you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
• if you are taking any form of organic nitrates or nitric oxide donors such as amyl nitrite. This is a group of medicines ("nitrates") used to treat angina pectoris ("chest pain"). It has been shown that tadalafil increases the effects of these medicines. If you are taking any form of nitrate or are unsure, tell your doctor.
• if you have a severe heart disease or have had a heart attack in the last 90 days.
• if you have had a stroke in the last 6 months.
• if you have low blood pressure or uncontrolled high blood pressure.
• if you have ever had loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "eye stroke".
• if you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs caused by blood clots). Phosphodiesterase type 5 inhibitors, such as tadalafil, have shown that they increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

Be aware that sexual activity carries a possible risk to patients with heart problems, due to the extra strain it puts on the heart. If you have a heart problem, consult your doctor.

As benign prostatic hyperplasia and prostate cancer can have the same symptoms, your doctor will check you for prostate cancer before starting treatment with tadalafil for benign prostatic hyperplasia. Tadalafil does not treat prostate cancer.

Before taking the tablets, tell your doctor if you have:

• sickle cell anemia (a condition that affects red blood cells).
• multiple myeloma (bone marrow cancer).
• leukemia (blood cell cancer).
• any deformation of the penis.
• a severe liver problem.
• a severe kidney problem.

It is not known if tadalafil is effective in patients who have been treated with:

• pelvic surgery.
• total or partial removal of the prostate gland in which the nerves of the prostate are cut (nerve-sparing radical prostatectomy).

If you experience sudden loss of vision or your vision is distorted, blurred, or diminished while taking tadalafil, stop taking tadalafil and contact your doctor immediately.

Sudden loss of hearing has been observed in some patients taking tadalafil. Although it is not known if the event is directly related to tadalafil, if you experience sudden loss of hearing, stop taking this medicine and contact your doctor immediately.

Tadalafil is not intended for use in women.

Children and adolescents

Tadalafil should not be used in children and adolescents under 18 years of age.

Other medicines and Tadalafil Zentiva

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Do not take tadalafil if you are already using nitrates.

Some medicines may be affected by tadalafil or may affect the way tadalafil works. Tell your doctor or pharmacist if you are using:

• an alpha-blocker (used to treat high blood pressure or symptoms of benign prostatic hyperplasia).
• other medicines to treat high blood pressure.
• riociguat.
• a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
• medicines such as ketoconazole tablets (for the treatment of fungal infections) and protease inhibitors for the treatment of HIV or AIDS.
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Taking Tadalafil Zentiva with food, drinks, and alcohol

Information about the effect of alcohol is in section 3. Grapefruit juice may affect the way tadalafil works and should be taken with caution. Consult your doctor for more information.

Fertility

In dogs treated with tadalafil, a decrease in sperm production by the testicles was observed. A reduction in sperm has been observed in some men. It is unlikely that these effects will produce a lack of fertility.

Driving and using machines

Some men who took tadalafil during clinical trials experienced dizziness. Check carefully how you react when taking the tablets before driving or using machines.

Tadalafil Zentiva contains lactose and sodium:

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Tadalafil Zentiva

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

The tablets of this medicine are for oral administration only in men. Swallow the tablet whole with a little water. The tablets can be taken with or without food.

Consuming alcohol may temporarily lower your blood pressure. If you have taken or plan to take tadalafil, avoid excessive alcohol consumption (blood alcohol level of 0.08% or higher), as it may increase the risk of dizziness when standing up.

For the treatment of erectile dysfunction

The recommended doseis one 5 mg tablet once a day, approximately at the same time. Your doctor may adjust the dose to 2.5 mg based on your response to tadalafil. This will be done by taking a 2.5 mg tablet. As Tadalafil Zentiva is not available in 2.5 mg film-coated tablets, the availability of other suitable formulations should be checked.

Do not take tadalafil more than once a day.

Tadalafil taken daily allows you to get an erection at any time during the 24 hours of the day, provided that there is sexual stimulation. Tadalafil taken daily may be useful in men who anticipate having sexual activity twice or more per week.

It is important to note that tadalafil is not effective if there is no sexual stimulation. You and your partner should stimulate yourselves in the same way as you would if you were not taking a medicine for erectile dysfunction.

Consuming alcohol may affect your ability to get an erection.

For the treatment of benign prostatic hyperplasia

The dose is one 5 mg tablet once a day, approximately at the same time. If you have benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg tablet once a day.

Do not take tadalafil more than once a day.

If you take more Tadalafil Zentiva than you should

Consult your doctor. You may experience side effects described in section 4.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken. It is recommended to take the package and the package leaflet of the medicine to the healthcare professional.

If you forget to take Tadalafil Zentiva

Take your dose as soon as you remember. Do not take a double dose to make up for forgotten doses. Do not take tadalafil more than once a day.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are usually mild to moderate.

If you experience any of the following side effects, stop using the medicine and seek medical help immediately:

• allergic reactions including rash (uncommon).
• chest pain - do not use nitrates, but seek medical help immediately (uncommon).
• priapism, a prolonged and possibly painful erection after taking tadalafil (rare). If you experience this type of erection, which can last continuously for more than 4 hours, you should contact a doctor immediately.
• sudden loss of vision (rare), distorted vision, blurred vision, or sudden loss of vision (frequency not known).

Other side effects that have been reported:

Common (may affect up to 1 in 10 people)

• headache, back pain, muscle aches, pain in arms and legs, facial flushing, nasal congestion, and indigestion.

Uncommon (may affect up to 1 in 100 people)

• dizziness, stomach pain, nausea, vomiting, reflux, blurred vision, eye pain, difficulty breathing, blood in the urine, prolonged erection, palpitations, rapid pulse, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of the hands, feet, or ankles, and feeling tired.

Rare (may affect up to 1 in 1,000 people)

• fainting, seizures, and transient loss of memory, swelling of the eyelids, red eyes, sudden loss of hearing, hives (red itchy patches on the skin), bleeding from the penis, blood in the semen, and increased sweating.

Heart attack and stroke have also been reported rarely in men taking tadalafil. Most of these men had pre-existing heart problems.

Sudden loss of vision, partial, transient, or permanent in one or both eyes has been reported rarely.

Some additional rare side effects have been reportedin men taking tadalafil that were not reported during clinical trials. These include:

• migraine, facial swelling, severe allergic reaction that causes swelling of the face or throat, severe skin rashes, certain disorders that affect blood flow to the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death.
• distorted vision, blurred vision, or sudden loss of vision (frequency not known).

In men over 75 years of age treated with tadalafil, the most frequently reported side effect was dizziness. In men over 65 years of age treated with tadalafil, the most frequently reported side effect was diarrhea.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) through the website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tadalafil Zentiva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. This will help protect the environment.

6. Contents of the pack and further information

Composition of Tadalafil Zentiva

• The active substance is tadalafil. Each tablet contains 5 mg of tadalafil.
• The other ingredients are:

Core of the tablet: lactose monohydrate, pregelatinized starch, colloidal anhydrous silica, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate.

Coating: hypromellose, lactose monohydrate, titanium dioxide (E171), triacetin, talc (E553b), yellow iron oxide (E172), red iron oxide (E172).

Appearance and packaging of the product

Tadalafil Zentiva 5 mg is a film-coated tablet (tablet), oval in shape, pale yellow in color, engraved with a "5" on one side and smooth on the other. The tablet is 10 mm x 6.0 mm in diameter and 3.3 - 3.9 mm in thickness.

Pack sizes

Tadalafil Zentiva 5 mg is available in blisters containing 14, 28, and 84 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Zentiva k.s.

U kabelovny 130

Dolní Mecholupy

102 37 Prague 10

Czech Republic

Manufacturer

Actavis Ltd

BLB016, Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

Balkanpharma Dupnitsa AD

3 Samokovsko Shosse Street

Dupnitsa, 2600

Bulgaria

Special Products's Line S.P.A.

Via Fratta Rotonda Vado Largo 1

03012 Anagni (FR)

Italy

You can obtain further information on this medicine by contacting the local representative of the marketing authorization holder:

Zentiva Spain S.L.U.

Avenida de Europa, 19, Edificio 3, Planta 1.

28224 Pozuelo de Alarcón, Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of this package leaflet: January 2024

Other sources of information:

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/